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Lester M. Crawford, Jr., D.V.M., Ph.D. - USDA

This text contains Dr. Crawford's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

USDA National Agricultural Research, Education,
Extension Advisory Committee meeting
on Biosecurity: Preparedness Plans

Remarks
by
Lester M. Crawford, Jr., D.V.M., Ph.D.

Deputy Commissioner
U.S. Food and Drug Administration
Washington, DC
March 28, 2002

Good afternoon. It's good to be here and see so many old friends and colleagues from my years with FSIS.

Just a few weeks ago, I returned to the Food and Drug Administration for my fourth stint with the agency. (I first joined the FDA's Bureau of Veterinary Medicine in 1975, and later came back as Director of the agency's Center for Veterinary Medicine -- not once, but twice.)

When I mentioned to friends that I am again returning to the FDA, the question was raised whether this was the best time to take charge of an agency that's on the front lines of our defenses against terrorism -- after all, FDA is responsible for the safety of almost 80 percent of the nation's food supply. And that's in addition to all animal feed and all cosmetics, as well as the safety and effectiveness of animal drugs and all health care products for humans.

Protecting so many vital products against a determined enemy is a considerable challenge. But I can honestly say that I find the FDA better prepared to confront a terrorist attack on regulated products, and particularly on food, than I had believed to be the case before I joined the agency several weeks ago. This is in part because of the familiar developments that all of us working in public health and nutrition have been concerned about in the last two decades.

One of them is the globalization of trade, which has led to a greatly increased volume and variety of foods imported from all over the world. Each increase in the multitude of sources and the length of transportation has unavoidably increased also the risks of contamination. Another hazard has been the growing dependence of our consumers on commercially prepared food -- so much so that 50 cents out of every food dollar is spent for meals in restaurants. Obviously, the more people handle the food, the greater the chance that it will become contaminated.

Add to this the fast-growing category of people at special risk for foodborne disease -- senior citizens; people with compromised immune systems; pregnant women and children -- plus the fact that in recent years scientists have identifed more than five times as many foodborne pathogens as were known fifty years ago.

The sum of all these factors spells a serious threat that was best expressed by the estimate of the Centers for Disease Control and Prevention that there occur in the United States about 76 million cases foodborne illness each year, causing 325,000 hospitalizations, 5,000 deaths, and a multibiliion-dollar economic damage.

Within the last decade or so, the FDA, USDA, CDC and other federal, state and local agencies involved in food safety have responded to this worrisome trend by mobilizing their scientific and other resources to fight food contamination and foodborne disease on three fronts:

  • One of them was the creation of FoodNet, PulseNet and NARMS, the National Antimicrobial Resistance Monitoring System. These systems, as you know, have among other functions improved the surveillance of foodborne outbreaks and microbial hazards, and speeded up traceback investigation of their origin.
    Faster tracebacks facilitate faster removal of the involved products, thereby saving lives. Incidentally, we're adding to this system yet another one -- eLEXNET, which is an Internet-based data exchange network for federal, state and local food safety laboratories.
  • The second prong of the defenses created in the last ten years has been a series of FDA rules and guidance documents aimed at preventing foodborne disease by keeping pathogens and other contaminants out of food.
    This was done by such actions as introducing HACCP into the processing of seafood and production of juice (as USDA did for meat and poultry); by publishing Good Agricultural Practices for fresh produce; and by implementing measures to improve the safety of sprouts and eggs.
  • The third main strategy has sought to reduce foodborne disease by educating the public on such essentials of food protection as proper techniques for storage, cleaning, cooking and other food preparation.

Much of this work has been done by a public-private coalition called Partnership for Food Safety Education, which included FDA and other government agencies as well as industry and consumer groups. The "Fight Bac!" campaign was a highlight of this effort.

These pillars of food safety were in place and helping protect the nation's health during the recent -- and in retrospect, balmy -- years when terrorism was something we certainly tried to prepare for, but our main worry was accidental contaminations.

Last September 11, the need for food protection assumed a whole new dimension, and we realized that although the existing food safety measures were a good basis for defense against terrorism, ensuring food security called for much broader and more vigorous actions. At FDA, we have been developing answers to the threat of food terrorism that fall into three categories:

  • anticipation;
  • deterrence;
  • and response.

In order to better meet a potential threat, we have to be able to anticipate where and in what form it may strike. That requires information: information about our food assets; understanding of their viability as carriers of possible contaminants; and -- to such extent as it is feasible -- intelligence about the capability and intent of potential aggressors who could target the food supply.

To acquire such wealth of data is beyond FDA's resources, but we're making gains, thanks to the help of many federal, state and local agencies, the intelligence community, and private industry. For example, the FDA has joined the U.S. Air Force's Office of the Surgeon General in mapping out a food safety and security strategy based on the framework of operational risk management.

This is an approach to security issues based on a systematic, six-step process that's been long used to improve safety and reduce losses in aircraft, space vehicles and nuclear power plants. We've already applied this methodology in developing -- together with industry -- two security guidances that were published in January.

One of the documents was issued for domestic food producers, processors, transporters, and retailers, and the other one for importers, brokers and others involved in importing products to this country. Both guidances outline measures that these firms can take to reduce the potential risk of a terrorist attack on food under their control.

The two guidances are, of course, intended to help deter food tampering or terrorism. FDA's most important deterrence strategy, however, is to strengthen its inspection, laboratory, compliance and enforcement staff and focus it on prevention of terrorism.

Congress has authorized us to spend for this purpose $151 million, $97 million of which we're using to improve safety and security of food. The FDA is now in the process of hiring 655 new employees for our field operations, 600 of whom will reinforce our food program. At least two-thirds of this total -- 400 -- will be primarily assigned to monitor imports.

They will substantially increase FDA's presence in our ports of entry, and we estimate that by the end of this year we will be able to conduct 24,000 import inspections, nearly double the total in the past. We should be able to double this number again when we have all of the new people on board and they are fully trained.

In addition, we are hiring more than 150 new chemists, microbiologists and other specialists who will analyze the collected samples in our laboratories. We're also planning to hire 84 compliance officers and investigators to handle import enforcement and support domestic inspections. Since the possibility exists that the terrorists would use contaminants not traditionally found in food, we are also bringing on board 30 additional specialists whose job will be performing risk assessments and developing rapid analytical methods for a variety of pathogens and types of products.

Finally, the Department of Health and Human Services has proposed a bill that would give FDA greater authority to protect our market against contaminated or disease-causing imported food. Among other provisions, the bill would strengthen FDA's ability to trace such food to its origin, rapidly contain an outbreak, and take effective measures against repeat violators of our rules for ensuring the safety of imported food.

Congress is currently considering two bills that address some of these measures. If passed, the legislation would add to FDA's response potential, which is the third component of our strategy to counter terrorism.

There are several factors involved in our response readiness, and we're addressing each of them.

  • We're fine-tuning our intelligence gathering efforts with the FBI, CIA and state and local law enforcement bodies. These contacts should provide us with an early warning about a potential terrorist threat and enable us to respond to it more effectively and in better coordination with others.
  • We're contacting state and government laboratories to get their assistance if an emergency should require rapid testing of more food samples than can be processed in FDA's facilities.
  • We're both conducting and funding research that should provide us with faster and more reliable tests to identify disease-causing bacteria and other contaminants in food, and help manufacturers develop processes to render them harmless.
  • Finally, we've held one emergency response exercise with the Department of Defense, CDC, the Environmental Protection Agency, the Nuclear Regulatory Commission, and foreign governments who are our partners on the counter-terrorism team.

We'll do more of such drills. They are designed to improve the coordination of our responses and make them more effective and appropriate to the potential emergencies.

The actions and provisions I've briefly described are, in a nutshell, the highlights of FDA's plans to meet the possible terrorist attack on our food.

They are well considered and based on sound science, which is the firm underpinning of every aspect of the FDA's public health mission. Of course, a terrorist attack on our food supply is not the only hazard we're concerned about. To mention just a few other issues, we must pay serious attention to the continuing threat of BSE, the developing antibiotic resistance, and the complexities of food biotechnology.

And I am not suggesting that the shield against terrorism which we are forging in collaboration with our many allies will ever be fool-proof. But as I said at the beginning of my remarks, I am encouraged -- by the scientific competence and high morale of our agency; by its support in Congress; and by the confidence FDA enjoys among the industries it regulates, as well as consumers. If, one day, the worst scenario should unfold, I am satisfied that we can count on the FDA to do its part protecting our public.